Biocon has established a large-scale, multi-product, cell culture facility which is the core technology in the manufacture of several important biologicals such as monoclonal antibodies and erythropoietin. Mammalian cells, being extremely sensitive to growth conditions such as shear, require equipment and processes that are quite different from microbial fermentation. Much of the nutrient media needs to be filter sterilized instead of steam sterilized to retain its nutritive value. The design of agitation, dissolved oxygen, pH control and cell recycle systems is also more complex.

Product recovery and purification suites are equipped with affinity, ion exchange and buffer exchange columns, diafiltration and ultrafiltration systems. All the operations are undertaken in clean rooms with strictly controlled environment to provide a high level of assurance in consistently achieving the best product quality.

This sophisticated manufacturing facility has been instrumental in supporting the launch of BioMab EGFR™ in 2006, a novel monoclonal antibody against SCCHN (head and neck cancer) and other cancers of epithelial origin. The facility is also equipped to supply the requirements for clinical development of other antibodies in Biocon’s research pipeline.